MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROSTHESIS

Catalog Number MB3355

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation can be conducted.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Current information are not sufficient to identify the root cause.Additional informations were requested.Investigation still in progress.Conclusion not available yet.

Event Description

Mobi-c p&f us : implant was loose on peek cartridge description received from the sales representative : surgeon states that device was loose on peek cartridge and did not feel comfortable implanting device.The alleged issue was identified prior tio insertion.Additional information received on june 26th 2018 from sales rep: the surgeon detected the issue before insertion.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Based on the product history records, the review of the case, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.No further information has been provided.It could not even be possible to make hypothesis about the root cause of the event.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: canot be established if additional informations were received that may add a value on this investigation or allow to drawn a conclusion another report will be sent.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7780065
• MDR Text Key: 116994690
• Report Number: 3004788213-2018-00255
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: MB3355
• Device Lot Number: 5301857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR